Fletcher Lydia C B, Burke Katie E, Caine Paul L, Rinne Natasha L, Braniff Charlotte A, Davis Hannah R, Miles Kathryn A, Packer Claire
College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.
GMS Health Technol Assess. 2013 Apr 11;9:Doc01. doi: 10.3205/hta000107. Print 2013.
Alzheimer's disease (AD) accounts for 60-80% of cases of dementia and causes significant morbidity in patients and carers, and expense for health and social services. There is a need for a validated, non-invasive and cheap test to diagnose early AD, as diagnosis may enable prompt treatment and service planning.
To identify emerging biomarker-based tests for the early diagnosis of AD which could be available for use in primary or generalist care in the near future.
Horizon scanning review.
We searched online sources to identify emerging non-invasive, biomarker-based tests. Tests were included if they used blood, saliva or urine; and there was evidence of use in trials in patients with AD. For tests licensed for use in clinical or research settings we requested information from the developer on the intended place of use and plans for availability in Europe.
We identified 6 biomarker-based tests of which 5 are available for research or clinical use. The closest to market were AclarusDX™ (ExonHit Therapeutics) a gene signature test, and INNO-BIA plasma Aβ forms assay (Innogenetics N.V.) which may be CE marked for clinical use in 2015. We found no evidence of clinical utility or cost.
Although biomarker-based tests are nearing clinical availability and may have a future role to help target AD-specific treatment and guide prognosis, they are not yet ready for trials of clinical utility in primary care.
阿尔茨海默病（AD）占痴呆病例的60 - 80%，给患者及其照料者带来严重的发病问题，并给卫生和社会服务带来费用负担。需要一种经过验证的、非侵入性且廉价的检测方法来早期诊断AD，因为早期诊断可能有助于及时治疗和制定服务计划。
确定基于生物标志物的新兴检测方法，用于AD的早期诊断，以便在不久的将来可用于初级或全科医疗。
前瞻性扫描综述。
我们检索在线资源以确定基于生物标志物的新兴非侵入性检测方法。如果检测方法使用血液、唾液或尿液，并且有在AD患者中进行试验的证据，则纳入该检测方法。对于已获临床或研究使用许可的检测方法，我们向开发者索取有关预期使用地点以及在欧洲上市计划的信息。
我们确定了6种基于生物标志物的检测方法，其中5种可用于研究或临床。最接近上市的是AclarusDX™（ExonHit Therapeutics公司）基因特征检测和INNO - BIA血浆Aβ形式检测（Innogenetics N.V.公司），后者可能在2015年获得CE标志用于临床。我们未发现有关临床效用或成本的证据。
尽管基于生物标志物的检测方法已接近临床应用，并且可能在未来有助于靶向AD特异性治疗和指导预后，但它们尚未准备好在初级保健中进行临床效用试验。
